多中心药物临床试验管理信息系统的开发

目的:拟解决我国多中心药物临床试验传统纸质管理方式落后、缺乏信息共享及协同管理等问题。方法:研究开发了一套基于J2EE跨平台技术体系的多中心药物临床试验管理信息系统,并介绍了其系统功能、技术架构及实现示例。结果与结论:该系统分为标准规范体系和信息安全两大体系,由基础层、数据层、支撑层、应用层和表现层五层结构组成;实现了药物临床试验项目信息、受试者信息、药品管理、质量控制等主要环节的信息化管理,对确保药物临床试验管理的时效性、规范性和提高管理效率有重要意义,适用于广域网络环境下多中心药物临床试验的信息化管理。

Development of Multicenter Drug Clinical Trial Management Information System

OBJECTIVE： To solve problems in the multicenter clinical drug trial of China： traditional paper-management is backward, information sharing and collaborative management is lacked. METHODS： To develope a multicenter drug clinical trial management information system （GCP system） based on J2EE cross-platform technology; function, technology architecture and demonstrations were introduced. RESULTS ＆ CONCLUSIONS： The system is divided into standard system and information safety, consisting of base layer, data layer, support layer, application layer and presentation layer. The system realizes information management in key link, such as project information management, the subjects of information management, drug management, quality control. It is important to ensure the timeliness, normalization and improve the management effectiveness, and is suitable for multicenter drug clinical trial information management under WAN environment.